NCT04224649Unknown不适用
A Single Center, Randomized, Subject & Evaluator-blind, Matched Pairs, Active-controlled Design Pivotal Study to Evaluate the Efficacy and Safety of Injection With HARA as Compared to Restylane® Lidocaine in Temporary Correction of Nasolabial Folds
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Assessment By independent evaluator
研究概览
简要总结
- Investigational Device : HARA (Hyaluronic Acid Filler)
- Title : A Single center, Randomized, Subject & Evaluator-blind, Matched pairs, Active-controlled design Pivotal study to Evaluate the Efficacy and Safety of Injection with HARA as Compared to Restylane® Lidocaine in temporary Correction of Nasolabial folds
- Sites and investigators : Chung-ang University Hospital(Seoul), Beom-Joon Kim, M.D, Ph.D
- Objective : To compare the non-inferiority of HARA with Restylane® Lidocaine for evaluation of the efficacy and safety on Nasolabial Folds
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who agreed to this treatment and signed the Informed Consent Form
- •Those who are 19 years old or more and desire to take correction of nasolabial folds
- •Those who have an intention of refraining from other cosmetic treatment(other filler injection, laser or chemical peeling, Botox injection or wrinkle reduction) during the clinical study period
- •Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least
排除标准
- •Those who are sensitive to lidocaine or other amide anesthesia
- •Those who are sensitive to control device
- •Those who are pregnant or lactating, or expect pregnancy
- •Those who are judged by the subinvestigator to be improper for this study
结局指标
主要结局
Assessment By independent evaluator
时间窗: Week 24 From baseline Visit(=Investigational Device Injection)
Wrinkle Severity Rating Scale (WSRS, Wrinkle severity Rating scale) \* Grade 1: Absent, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe, Grade 5: Extereme
次要结局
未报告次要终点
研究者
研究点 (1)
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